pAVEway™ Expression System for the Efficient Expression of Therapeutic Proteins
One of the major bottlenecks in the production of biopharmaceuticals is the efficient expression of therapeutic proteins in microbial or mammalian cells.
Biopharmaceutical Process Development and Manufacturing Services
Belasis Avenue,
Billingham,
TS23 1LH County Durham,
United Kingdom
Fujifilm Diosynth Biotechnologies is one of the world’s leading providers of contract process development and manufacturing services for the biopharmaceutical industry.
Formed in April 2011, the company has more than 900 employees operating from two sites in Billingham, UK, and Research Triangle Park, North Carolina, US.
Together we have more than 15 years of experience working with over 230 complex proteins, and both sites have been successfully FDA inspected for the manufacture of commercial products, demonstrating our strong track record in navigating the critical path through validation and regulatory approval.
Over the last 12 months, we have announced additional mammalian cell culture capacity at both our RTP site (commissioned early 2012) and a new cGMP mammalian cell culture facility at our Billingham, UK site (commissioned Q3 2013).
A ‘one-stop-shop’ is available for antibody drug conjugate (ADC) development through our alliance with Piramal Healthcare. The combined ADC development between Fujifilm and Piramal ensure rapid conjugation demonstration and route to market.
As a full-service contract manufacturer, we offer an extensive breadth of process development capabilities to meet our customers’ needs at every stage of the product lifecycle.
Our experience ensures process development is applied appropriately, dependent upon the development needs of customer products at different clinical stages.
We offer:
At our sites in Billingham, UK, and Research Triangle Park, NC, US, we offer a broad range of mammalian and microbial cGMP manufacturing capabilities. We employ protocol-driven technology transfer processes to bring in projects from customers and seamlessly integrate them into these facilities. Our facilities have received successful regulatory inspections from all key regulatory agencies.
Microbial:
Mammalian:
The following additional services are offered to reduce complexity and risk of multiple suppliers:
Our aims include:
We can also offer a ‘one-stop-shop’ for antibody drug conjugates through our alliance with Piramal Healthcare. Through our rapid delivery of ADC drug substance, simplified supply chain and aligned mAb and ADC programmes the benefits include:
One of the major bottlenecks in the production of biopharmaceuticals is the efficient expression of therapeutic proteins in microbial or mammalian cells.
In 2002 the US Food and Drug Administration began its initiative to modernise the regulation of pharmaceutical manufacturing and product quality
Fujifilm Diosynth Biotechnologies (FDB) began the construction of its Advanced Therapies Innovation Centre in College Station, Texas, US.
Fujifilm Diosynth Biotechnologies (FDB) embarked on an expansion of its flexible biomanufacturing facility at its College Station location in Texas, US, in February 2020.
Fujifilm Diosynth Biotechnologies (FDB) is building a Biocampus at its Billingham, UK site.
Samsung BioLogics opened its third biologics manufacturing plant in Songdo, South Korea, in October 2018. The plant made Samsung Group one of the world’s largest biologics contract manufacturing operators (CMO) in the world.
In February 2018, Ferring Pharmaceuticals announced plans to build a new biotechnology centre at its headquarters in Saint-Prex, Switzerland.
Chinese company Clover Biopharmaceuticals plans to build a new biomanufacturing facility in the Changxing Economic and Technological Development Zone (CETDZ) of Zhejiang, China.
Pfizer broke the ground for the development of a Global Biotechnology Centre in the Hangzhou Economic Development Area (HEDA) in China on 27 June 2016.
FUJIFILM Diosynth Biotechnologies has announced the continued expansion of its cell culture manufacturing capabilities with the addition of two 2,000l single-use bioreactors. One of each of these is being installed at the company's sites in Research Triangle Park (RTP), NC, US and Billingham, UK.
Fujifilm Diosynth Biotechnologies has announced continued expansion of its process development capabilities with the investment of over $5.6m in new laboratories and equipment at both its Billingham, UK, and Research Triangle Park (RTP), NC, US sites.
Fujifilm Diosynth Biotechnologies has formally opened its new UK mammalian cell culture cGMP manufacturing facility at a ceremony performed by HRH the Duke of Gloucester.
Fujifilm Diosynth Biotechnologies has announced that it has received a renewal of its manufacturer's licence from the UK's Medicines and Healthcare products Regulatory Agency (MHRA).
Fujifilm Diosynth Biotechnologies has announced that it has commissioned on time its new mammalian cGMP Cell Banking Facility (CBF) at its Billingham, UK site.
Fujifilm Diosynth Biotechnologies has added another licensed product to its list of commercial biopharmaceutical products, following the announcement that ThromboGenics' has received FDA approval for the launch of JETREA® (ocriplasmin) in the USA for the treatment of Symptomatic Vitreomacular Adhesion (VMA).
Fujifilm Diosynth Biotechnologies has announced it has entered into a strategic alliance with Piramal Healthcare UK, whereby the two parties will offer the seamless contract development and manufacture of antibody drug conjugates (ADCs), a growing niche in the development of biopharmaceuticals.
Fujifilm Diosynth Biotechnologies has announced it is expanding its services in mammalian cell line development / process development and adding a new multiproduct cGMP facility at its Billingham, UK site, further increasing its contract process development and manufacturing capabilities.
Fujifilm Diosynth Biotechnologies has completed the first phase of a £3m ($4.5m) investment in new equipment and laboratories at its Billingham, UK site.
Fujifilm Diosynth Biotechnologies and ContraFect Corporation have signed a contract to support the process development and cGMP manufacture of CF-301, ContraFect's Staphylococcal-specific bacteriophage lysin.
Fujifilm Diosynth Biotechnologies is to add a 1,000l Xcellerex® single-use bioreactor to its RTP, North Carolina facility, in order to expand its existing contract manufacturing capabilities. This expansion reinforces the commitment to lead the global biologics CMO industry through continuou
Fujifilm Diosynth Biotechnologies has been announced as the new name for the former Merck BioManufacturing Network (known as MSD BioManufacturing Network outside the US and Canada) following completion of its acquisition today by FUJIFILM Corporation of Japan. As previously announced, t
Fujifilm Corporation and Merck, known as MSD outside the US and Canada, have announced that they have entered into a definitive agreement by which Fujifilm will acquire the Merck BioManufacturing Network, a leading provider of contract manufacturing and development services for the biopharmaceut
Nuron Biotech has selected the Merck BioManufacturing Network in the UK to manufacture large-scale GMP clinical supplies of NU100 and undertake process validation leading to long-term commercial operations. NU100 is a proprietary recombinant human interferon beta compound being developed for the
Belasis Avenue
Billingham
TS23 1LH
County Durham
United Kingdom
101 J.Morris Commons Lane
Morrisville, NC 27560
Other
United States of America